Actively Recruiting
Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-12-31
256
Participants Needed
6
Research Sites
370 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study investigators hypothesize that the intervention of case managers specifically trained in case management of early psychosis will change the paradigm of care of a first psychotic episode from the current organization of the care system. Indeed, the creation of specific services for emerging psychotic disorders cannot easily be generalized throughout the country and requires specific funding. The intervention of case managers according to the recommendations of good practices will make it possible to propose the fundamental principles of early intervention to young patients and their families on a large scale throughout the territory, namely: personalized and proactive accompaniment, psycho-education of the pathology and treatments, involvement and support of the families, and support for socio-professional reintegration
CONDITIONS
Official Title
Evaluation of the Impact of Case Manager Intervention on the 3-year Psychotic Episode Recurrence Rate in Patients Aged 16 to 30 Years With a First Psychotic Episode.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient or their close relative must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is available for a 3-year follow-up
- Patient is managed in a psychiatric service (consultation or hospitalization) for a first episode psychosis defined by presence of positive psychotic symptoms evolving for at least one week, either daily or at least 3 times per week for at least one hour per occasion
- Patient has never taken neuroleptic treatment aimed at antipsychotic use prior to current episode treatment
- Patient has a disorder meeting DSM 5 criteria including delusional disorder, brief psychotic disorder >7 days, schizophreniform disorder, schizophrenia, schizoaffective disorder, substance-induced psychotic disorder >7 days, other schizophrenic spectrum or psychotic disorders, bipolar I or II disorder with psychotic features, or major depressive disorder with psychotic features
- Inclusion should be within the first 3 months of care for first episode psychosis
- Psychotic symptomatology may still be present or in remission at inclusion
You will not qualify if you...
- Participating in another category I interventional study or within an exclusion period from a prior study
- Refusal to sign consent by patient or parent (if minor)
- Inability to provide informed information to the subject
- Patient under safeguard of justice or state guardianship
- Patient has IQ less than or equal to 55
- First psychotic episode linked to a psychotic problem triggered by medication or other medical condition
- Patient is pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 6 locations
1
CHU de TOULOUSE
Toulouse, Choisir Une Région, France, 31
Not Yet Recruiting
2
CH Saint Marie Clermont-Ferrand
Clermont-Ferrand, France
Not Yet Recruiting
3
CHU de Montpellier
Montpellier, France
Actively Recruiting
4
CHU Nice
Nice, France
Not Yet Recruiting
5
CHU de Nîmes
Nîmes, France
Actively Recruiting
6
Centre Hospitalier Léon-Jean Grégory
Thuir, France
Actively Recruiting
Research Team
A
Aurélie Schandrin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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